Merck KGaA's pimicotinib, an investigational medicine developed by Abbisko Therapeutics Co., Ltd., has demonstrated a significant improvement in objective response rate in patients with tenosynovial giant cell tumor (TGCT) in the Phase III MANEUVER trial, meeting its primary endpoint. The study's findings mark a potential advancement in the treatment of this rare tumor.
The MANEUVER trial revealed that the objective response rate for pimicotinib at week 25 was 54.0%, compared to a mere 3.2% for the placebo group. This substantial difference underscores the potential clinical benefit of pimicotinib for TGCT patients.
Secondary Endpoint Improvements
The trial also assessed secondary endpoints related to patient outcomes. Treatment with pimicotinib resulted in statistically significant and clinically meaningful improvements in stiffness, as measured by the Numeric Rating Scale, and pain, assessed by the Brief Pain Inventory. These improvements suggest a comprehensive benefit in managing the symptoms associated with TGCT.
Safety and Tolerability
In terms of safety, pimicotinib was well-tolerated by patients in the MANEUVER trial. The safety profile observed was consistent with previously reported data, and notably, there was no evidence of cholestatic hepatotoxicity. This favorable safety profile is an important consideration for a treatment intended for long-term use in patients with TGCT.
